ANDA 215069

SCIEGEN PHARMS INC

FDA Drug Application

Application #215069

Documents

• Letter: 2021-07-14
• Letter: 2021-07-14

Application Sponsors

ANDA 215069

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	750MG	0	LEVETIRACETAM	LEVETIRACETAM
002	TABLET;ORAL	1GM	0	LEVETIRACETAM	LEVETIRACETAM
003	TABLET;ORAL	250MG	0	LEVETIRACETAM	LEVETIRACETAM
004	TABLET;ORAL	500MG	0	LEVETIRACETAM	LEVETIRACETAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-06-11	STANDARD
UNKNOWN;	ORIG	2	TA	2021-06-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215069
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2021","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-11
        )

)